New clinical guidelines, new patient populations
If a medicinal product (MP) contains new chemical compounds
If major changes concerning the product safety were introduced in the package insert (PI) tested earlier
Если ЛП выпускается в принципиально новых лекарственных формах или изменились условия отпуска ЛП
A detailed testing report for your MP will support successful marketing authorization of the MP by the authorized bodies.
To user testing, strictly abiding by protocols and requirements of the authorized bodies.
We customize the testing process with account of key safety requirements of your medicinal drug.
We enroll respondents by age, sex, specifically for your project and according to the requirements of EEC No 88.
Transparent testing process: testing schedule, questions and conditions of testing are available to you prior to its start.
Intermediate reports. You receive reports after every testing stage and can made amendments based on the pilot or first stage testing outcomes.
At the end of the 3 stages of testing you receive a final user testing report including individual demographic data of participants, and a summary report.